Trial NCT03852537
Publication SMART Trial - Odeyemi YE, Crit Care (2022) (published paper)
Dates: 2020-03-01 to 2020-11-30
Funding: Public/non profit (The American Heart Association COVID-19 Rapid Response Grant. The Mayo Clinic Critical Care Independent Multidisciplinary Program (IMP) Research Grant (Institutional Departmental grant). National Center for Advancing Translational Science (NCATS). National Heart, Lung, and Blood Institute)
Conflict of interest: No

Methods
RCT
Blinding: single blinding
Location : Single center / USA
Follow-up duration (days): 90
Inclusion criteria
  • Patients admitted to hospital with COVID-19 pneumonia (high suspicion or confirmed by positive SARS CoV-2 testing)
  • Acute respiratory failure SpO2/FiO2 < 315 (SpO2<90% on room air or <97% on 2L NC).
Exclusion criteria
  • Contraindications or unwilling to use steroids by patient or provider
  • Refractory septic shock defined as a requirement of norepinephrine dose or equivalent above >0.1 microgram/kilogram/minute or 2 or more vasopressors
  • Pre-admission chronic use of steroids or other immunosuppressive medications
  • Adrenal insufficiency
  • Comfort care Leukopenia <1000/mm or neutropenia <500/mm (except if attributable to pneumonia) and HIV positive with a CD4 count <100
  • Recent or past history of bone marrow or solid organ transplantation
  • Suspected flare of Interstitial lung disease (infectious and non-infectious)
  • Positive influenza testing or high suspicion for influenza
Interventions
Treatment
Methylprednisolone
0.5 to 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone) adjusted to daily CRP level.
Control
Standard care

Participants
Randomized
participants :
Methylprednisolone=19
Standard care=22
Characteristics of participants
N= 41
Mean age : NR
24 males
Severity : Mild: n=4 / Moderate: n=25 / Severe: n=14 Critical: n=2
Number of vaccinated participants: NR
Primary outcome
In the register
Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing [ Time Frame: Within 30 days of enrollment in study. ] Number of eligible subjects to adhered to the timely initiation and daily corticosteroid treatment according to ESICM/Society of Critical Care Medicine SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)
In the report
feasibility of the trial protocol
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
High
General comment In addition to the published article, the registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. This pilot trial was originally planned and registered in early 2019 to investigate biomarker-guided corticosteroid use in pneumonia and acute hypoxemic respiratory failure. A separate COVID-19 arm was added in 2020. There was a change to standard care due to the results of the RECOVERY trial. The primary feasibility outcome in the article reflects that in the registry and all planned outcomes are reported in the registry.
Results were also posted on the trial registry but data from direct contact with authors was given priority.
This study was updated on April 28th, 2022 with data acquired after contact with authors.